A Pilot Study to Exam the Flexibility, Safety and Efficacy of Using Microwave Ablation in Patients With Ground Glass Nodules
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of participants recruited; Number of participants complied with protocol; Number of participants finished the study; Number of participants withdrew from the study
研究概览
简要总结
In order to conduct a multicenter comparative effectiveness clinical research of phase II to investigate safety and efficacy of applying microwave ablation in patients with Great-glass lung nodules ≤ 3cm, a single center, non-randomized, open label pilot study is conducted to examine the flexibility, safety and efficacy of using Microwave Ablation in Patients with Ground Glass Nodules that are poor candidate of surgery.
详细描述
Lung cancer is the most common cancer worldwide contributing 13% of the total number of new cases diagnosed. The main treatments of lung cancer are based on surgical resection and adjuvant postoperative chemotherapy. However, the patients who are intolerant of surgery wouldn't be benefit from surgical resection. Microwave ablation provide new choice for lung cancer, which can effectively treat early lung cancer. The diagnosis of early lung cancer can be based on the results of biopsy of ground-glass nodules (GGNs), which is one of the diagnostic criteria for preoperative diagnosis of early lung cancer. The microwave ablation is the good choice for patients who cannot tolerate surgical resection. However, the flexibility, safety and efficacy of using Microwave Ablation in Patients with Ground Glass Nodules are still unclear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent, inclusive of release of medical information.
- •Age ≥ 18 years
- •CT scan indicates presence of Ground Glass Lung Nodules less than 30mm
- •Willing to comply with all protocol required follow-up: 30 days and 90 days post microwave ablation
- •Patients who cannot tolerate surgical resection due to cardiopulmonary dysfunction and advanced age
- •Patients who refuse surgical resection
- •Patients who don't have serious complications
排除标准
- •Unable to give informed consent or potential for noncompliance with the study protocol in the judgement of the investigator
- •Pregnant or breast-feeding at time of screening
- •Active skin infection and ulceration around the percutaneous site
- •Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis
- •Tendency of severe bleeding, platelets less than 50 × 109 / L and severe blood coagulation disorders. Anticoagulant therapy and/or antiplatelet agents should be discontinued for at least 5d-7d before microwave ablation.
- •Ablation of the ipsilateral malignant pleural effusion is not well controlled
- •Liver, kidney, heart, lung, brain dysfunction, severe anemia, dehydration and serious disorders of nutritional metabolism, cannot be corrected or improved in the short term, severe systemic infection, high fever (> 38.5 oC)
- •Extensive extrapulmonary metastasis, expected to survive < 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status > 3
研究组 & 干预措施
Use CT-guided microwave ablation in Ground Glass Nodules ≤ 3cm
Patients with Ground Glass Nodules ≤ 3cm were treated with CT-guided microwave ablation
干预措施: CT-guided microwave ablation (Procedure)
结局指标
主要结局
Number of participants recruited; Number of participants complied with protocol; Number of participants finished the study; Number of participants withdrew from the study
时间窗: 6 months
Feasibility data that help identify potential population target of CT-guided microwave ablation
次要结局
- Number of participants with treatment-related adverse events assessed by CTCAE v4.0(6 months)
- Number of participants successfully removed ground glass nodules and no relapse in follow-up visit(6 months)
- Confounding variables identified that interfere with efficacy of microwave ablation(6 months)